New TGA guidance clarifies requirements for compounded medicines

The Therapeutic Goods Administration (TGA) has published new guidance on Manufacturing, supplying and advertising compounded medicines lawfully, to support compliance with Australia’s regulatory requirements.

The TGA encourages the use of medicines included in the Australian Register of Therapeutic Goods (ARTG). However, the legislative framework recognises that compounding may be necessary in limited circumstances to meet an individual patient’s clinical needs.

The guidance explains how community and hospital pharmacists, medical practitioners and other relevant health practitioners can lawfully compound medicines under the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990. This includes when exemptions may apply from manufacturing licensing requirements and inclusion in the ARTG.

The guidance also outlines additional restrictions and expectations for higher-risk products, including biologicals, medicinal cannabis, GLP-1 receptor agonist analogues and intravenous (IV) therapies.

Health practitioners who compound medicines should review the guidance and check that their compounding, supply and advertising practices comply with legal and professional requirements and any applicable exemptions.

This publication forms part of the TGA’s ongoing work to support regulatory clarity and promote consistent, lawful practice across the health sector.

Where serious non-compliance with the Act is identified, the TGA will take regulatory action in line with its regulatory compliance framework. This may include issuing infringement notices, directions or prevention notices, or pursuing civil or criminal proceedings. Penalties for breaches of the Act include civil penalties of up to $1.65 million per breach for individuals or $16.5 million per breach for corporations, as well as fines or imprisonment.

If you suspect non-compliance relating to therapeutic goods, including advertising, you can report it to the TGA at any time.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400